MedPath

Innovative Multimodal and Attention Training to Improve Emotion Communication in Veterans With TBI and PTSD

Not Applicable
Recruiting
Conditions
Post Traumatic Stress Disorder
Brain Injury
Interventions
Behavioral: Multimodal affect recognition training
Behavioral: Brain Health Workshop
Behavioral: Attention Training
Behavioral: National Geographic Movies
Registration Number
NCT05478759
Lead Sponsor
VA Office of Research and Development
Brief Summary

Poor emotion recognition has been associated with poor quality of interpersonal relationships, loss of employment, behavioral problems, reduced social reintegration, social isolation and even suicide. Deficits in emotion recognition are common in traumatic brain injury (TBI) and in post-traumatic stress disorder (PTSD) but these deficits have not been well studied in Veterans with both mild TBI (mTBI) and PTSD. Currently there are no interventions for emotion recognition in Veterans with mTBI and PTSD, and interventions for severe TBI have lacked training of both facial and vocal emotion recognition. In a preliminary study of an innovative combination of facial and vocal modalities, a multimodal affect recognition training (MMART) showed promise but lacked attention training that is an essential component in recognizing emotions in our daily lives. Given the need to improve relationships and productivity in Veterans with mTBI and PTSD, a study is needed to determine the effectiveness of a MMART combined with attention training.

Detailed Description

Background. Deficits in emotion recognition are common in traumatic brain injury (TBI) and in post-traumatic stress disorder (PTSD) but these deficits have not been well studied in Veterans with both mild TBI (mTBI) and PTSD. Poor emotion recognition has been associated with poor quality of interpersonal relationships, loss of employment, behavioral problems, reduced social reintegration, social isolation and even suicide. Currently there are no interventions for emotion recognition deficits in Veterans with mTBI and PTSD, and interventions conducted in civilians with severe TBI have lacked training of both facial and vocal emotion recognition. In a preliminary study of an innovative combination of facial and vocal modalities, a multimodal affect recognition training (MMART) showed promise with significant improvement on the Florida Affect Battery (FAB) but lacked attention training that is an essential component in recognizing rapidly changing emotions in our everyday lives. Attention training using Brain HQ targets the required attention factors underlying emotion recognition. Given the need to improve relationships and productivity in Veterans with mTBI and PTSD, a randomized controlled trial is needed to determine the effectiveness of an innovative MMART combined with attention training to improve emotion recognition and everyday function.

Objective \& Hypotheses. The objective of this randomized controlled trial is to determine the treatment effect of a MultiModal Affect Recognition Training (MMART) combined with attention training in Veterans with TBI/PTSD.

Hypothesis 1. MMART combined with attention training will significantly improve performance on tests of emotion recognition.

Hypothesis 2: Treatment gains will translate to functional activities. Primary measures. Florida Affect Battery (FAB) and the Community Reintegration in Service members (CRIS).

Secondary measures. Emotion Recognition Task (ERT), attention index of the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS), the Continuous Performance Task and the TBI Quality of Life (TBI-QOL) Ability to Participate in Social Roles and Activities.

Methods. 20 Veterans with mTBI and PTSD will be randomized to either the combined training or an inactive control group. Both groups will attend 16, one-hour in-person sessions over 8 weeks. Outcomes will be assessed at pre-, post-, 3 month-post-treatment. A linear regression will be used to determine significant improvement of the treatment group over the control group, with t-tests to demonstrate within group improvement. Effect size calculations will be used to determine the power needed for a future Merit proposal.

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
20
Inclusion Criteria
  • Veterans with a diagnosis of mTBI and PTSD based on VA/Department of Defense guidelines.
  • Emotion recognition deficit
  • Attention deficit
  • Corrected vision within normal limits
  • Hearing within normal limits
  • Fluent in English
Exclusion Criteria
  • premorbid history of schizophrenia
  • bipolar disorder
  • chronic medical or neurological diseases

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
MMART and attention trainingAttention TrainingTraining to recognize affect and prosodic expressions of emotions combined with attention training.
MMART and attention trainingMultimodal affect recognition trainingTraining to recognize affect and prosodic expressions of emotions combined with attention training.
Brain Health Workshop and National Geographic MoviesNational Geographic Moviesan inactive arm that matches sessions of intervention. BHW is education about the brain and cognition. National Geographic movies are viewed with the clinician and the participant answers questions about the movies.
Brain Health Workshop and National Geographic MoviesBrain Health Workshopan inactive arm that matches sessions of intervention. BHW is education about the brain and cognition. National Geographic movies are viewed with the clinician and the participant answers questions about the movies.
Primary Outcome Measures
NameTimeMethod
Florida Affect Battery (FAB), assessing changeweek 1, week 11, week 22

a standardized assessment of emotional affect and prosody recognition. normative scores range from 0-100 for each of the 12 subscales. Higher scores indicate better emotion recognition.

Community Reintegration of Service Members, assessing changeweek 1, week 11, week 22

Satisfaction questionnaire of community participation. Scores range from .43 to 2.15. 43 items with five rating options of 1-5. Higher scores indicate better community participation.

Secondary Outcome Measures
NameTimeMethod
Continuous Performance Task, assessing changeweek 1, week 11, week 22

computerized measures of sustained attention. 100 trials with accuracy ranging from 0-100 (higher scores indicate better attention) and response time from 0-60 (lower scores indicate quicker response time).

Emotion Recognition Task, assessing changeweek 1, week 11, week 22

computerized assessment of emotional affect recognition. Correct responses range from 0-48 (higher scores indicate better emotion recognition) and correct response time ranges from 0 to infinity (lower scores indicate quicker response time).

Attention Index of the Repeatable Battery for the Assessment of Neuropsychological Status, assessing changeweek 1, week 11, week 22

digit span and symbol digit to assess attention. Scaled scores range from 1-19, with higher scores indicating better attention.

Traumatic Brain injury quality of lifeweek 1, week 11, week 22

quality of life questionnaire about community participation. 59 items with scores ranging from 59-295, with higher scores indicating better community participation.

Trial Locations

Locations (1)

North Florida/South Georgia Veterans Health System, Gainesville, FL

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Gainesville, Florida, United States

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